<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Ardashel Latsuzbaia</style></author><author><style face="normal" font="default" size="100%">Severien Van Keer</style></author><author><style face="normal" font="default" size="100%">Vanden Broeck, Davy</style></author><author><style face="normal" font="default" size="100%">Weyers, Steven</style></author><author><style face="normal" font="default" size="100%">Gilbert Donders</style></author><author><style face="normal" font="default" size="100%">Philippe De Sutter</style></author><author><style face="normal" font="default" size="100%">Wiebren Tjalma</style></author><author><style face="normal" font="default" size="100%">Jean Doyen</style></author><author><style face="normal" font="default" size="100%">Alex Vorsters</style></author><author><style face="normal" font="default" size="100%">M. Arbyn</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Clinical Accuracy of Alinity m HR HPV Assay on Self- versus Clinician-Taken Samples Using the VALHUDES Protocol.</style></title><secondary-title><style face="normal" font="default" size="100%">J Mol Diagn</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Early Detection of Cancer</style></keyword><keyword><style  face="normal" font="default" size="100%">Female</style></keyword><keyword><style  face="normal" font="default" size="100%">Human Papillomavirus Viruses</style></keyword><keyword><style  face="normal" font="default" size="100%">Humans</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomaviridae</style></keyword><keyword><style  face="normal" font="default" size="100%">Papillomavirus Infections</style></keyword><keyword><style  face="normal" font="default" size="100%">Sensitivity and Specificity</style></keyword><keyword><style  face="normal" font="default" size="100%">specimen handling</style></keyword><keyword><style  face="normal" font="default" size="100%">Uterine Cervical Dysplasia</style></keyword><keyword><style  face="normal" font="default" size="100%">Uterine Cervical Neoplasms</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2023</style></year><pub-dates><date><style  face="normal" font="default" size="100%">2023 Dec</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">25</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;The VALHUDES protocol was established to evaluate clinical accuracy of human papillomavirus (HPV) assays to detect cervical precancer on first-void urine (FVU) and vaginal self-samples versus matched clinician-collected cervical samples (CCSs). Here we evaluated clinical performance of Alinity m HR HPV assay in a colposcopy referral population. Home-collected FVU (Colli-Pee FV 5020) 1 day before colposcopy (n = 492), at-clinic collected dry vaginal self-samples [multi-Collect Swab (mC; n = 493), followed by Evalyn Brush (EB; n = 233) or Qvintip (QT; n = 260)] and matched CCSs, were available for the study. Sensitivity to detect cervical intraepithelial neoplasia grade 2 or higher (CIN2) of Alinity testing on FVU (ratio,&amp;nbsp;0.94; 95% CI, 0.85-1.03), mC (ratio,&amp;nbsp;1.00; 95% CI, 0.94-1.06), and EB/QT (ratio,&amp;nbsp;0.92; 95% CI, 0.85-1.00) was not different to CCSs. Specificity on FVU was similar to CCS (ratio,&amp;nbsp;1.02; 95% CI, 0.95-1.10), whereas specificity on mC was lower (ratio,&amp;nbsp;0.83; 95% CI, 0.76-0.90), but on EB/QT was higher (ratio,&amp;nbsp;1.08; 95% CI, 1.01-1.15) than on CCS. Accuracy on EB (sensitivity ratio,&amp;nbsp;0.96; 95% CI, 0.87-1.05; specificity ratio,&amp;nbsp;1.18; 95% CI, 1.06-1.31) was slightly better than on QT (sensitivity ratio,&amp;nbsp;0.88; 95% CI, 0.75-1.03; specificity ratio,&amp;nbsp;1.00; 95% CI, 0.92-1.09). In conclusion, clinical sensitivity of Alinity assay on all self-sample types was similar to cervical specimens. Adjustment of signal thresholds improved assay's accuracy to detect CIN2 in all self-sample types.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">12</style></issue></record></records></xml>